Fasudil hydrochloride pharmaceutical composition for injection

Abstract

The invention discloses a pharmaceutical composition of fasudil hydrochloride for injection. The fasudil hydrochloride injection is composed of fasudil hydrochloride, cysteine ​​hydrochloride and sodium chloride, each containing hydrochloric acid method Sudil 15-60mg, cysteine ​​hydrochloride mg, sodium chloride mg. The preparation method is as follows: take 90% of the prescribed amount of water for injection, at a temperature of 55-65°C, add the prescribed amount of cysteine ​​hydrochloride, stir to dissolve; add the prescribed amount of fasudil hydrochloride, stir until dissolved, and pour into Then add the sodium chloride of recipe quantity in the solution, stir until dissolving completely; Measure initial pH value, according to initial pH value, adjust pH value range with 4% sodium hydroxide solution and 10% cysteine ​​hydrochloride solution in 5.5- 6.5; add medicinal charcoal to the mixture, stir; suction filter, add water for injection to the full amount, mix evenly; fine filter; fill; sterilize; The pharmaceutical composition of fasudil hydrochloride has good light stability, no crystallization and clarity, and good stability. The invention has the advantages of improving product yield, reducing cost, realizing industrialization, and better clinical application. more obvious advantages.

Description

technical field [0001] The invention relates to medicines in the field of medicine, in particular to a fasudil hydrochloride pharmaceutical composition for injection that is stable to light, does not produce crystals, and has good stability and a preparation method thereof. Background technique [0002] In recent years, subarachnoid hemorrhage following cerebrovascular accidents such as ruptured aneurysms has become well known to clinicians. The most common and serious complication of subarachnoid hemorrhage is cerebral vasospasm. The main cause of disability or death is delayed cerebral ischemia caused by arterial spasm. Nearly half of the patients occur after hemorrhage. If no treatment is given , the incidence of neurological deficit or death is as high as 20%. Although the potential risk of cerebral vasospasm is great, the mechanism of its pathogenesis is not yet fully understood, and it is generally considered to be the result of a combination of multiple reasons. The...

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Problems solved by technology

[0003] At present, nimodipine is the most widely used calcium antagonist in clinical practice. Its problem is that its selectivity to cerebrovascular is not strong, and it also lowers systemic blood pressure while relaxing cerebrovascular.

[0015] The Fasudil Hydrochloride Injection produced by the prior art has very strict requirements on storage and protection from light, and is inconvenient in use, storage and transportation

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